Plain English Summary
Background and study aims
Hypoxic training involves training while breathing hypoxic (low oxygen) air. Although not commonly used, hypoxic training may be beneficial for people with clinical conditions such as coronary artery (heart) disease and chronic obstructive pulmonary (lung) disease. However, the effects of hypoxic training vary greatly according to the oxygen level, exercise intensity, time and duration, and also vary considerably among individuals. The aim of this study is to examine the effects of hypoxic training on factors related to metabolic syndrome (a combination of diabetes, high blood pressure and obesity).
Who can participate?
Men aged 18 or over
What does the study involve?
Participants are divided into two groups based on their body mass index. Participants in the overweight and normal-weight groups are then randomly allocated into either the hypoxic exercise group (hypoxic overweight and hypoxic normal-weight) or the normoxic exercise group (normoxic overweight and normoxic normal-weight). Participants perform treadmill exercise three days per week for four weeks under either hypoxic (low oxygen) or normoxic (normal oxygen) conditions, for 50 minutes (including 5 minutes warm-up and cool-down periods) after a 30-minute rest period. Markers of metabolic syndrome are measured using blood sampling at the start and the end of the study.
What are the possible benefits and risks of participating?
These results may show that hypoxic training could be useful for improving arterial (blood vessel) stiffness, circulatory system function, body composition and metabolism in adult men.
Where is the study run from?
Gifu University (Japan)
When is the study starting and how long is it expected to run for?
March 2014 to May 2015
Who is funding the study?
University of Ulsan (South Korea)
Who is the main contact?
Dr Sohee Shin
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
-
Study information
Scientific title
Influences of short-term normobaric hypoxic training on metabolic syndrome-related markers in overweight and normal-weight men: a randomised controlled trial
Acronym
Study hypothesis
Short-term normobaric hypoxic training influences metabolic syndrome-related markers in overweight and normal-weight men positively.
Ethics approval
Institutional review board of the Gifu University School of Medicine, 06/03/2013, ref: 24-392
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Metabolic syndrome
Intervention
Forty-one Japanese men were included and were divided into two groups based on their body mass indexes (BMIs): BMI ≥25 or BMI <25. Participants in the overweight and normal-weight groups were randomised into the hypoxic exercise group (hypoxic overweight, HO; hypoxic normal-weight, HN) or the normoxic exercise group (normoxic overweight, NO; normoxic normal-weight, NN). Subjects performed treadmill exercise three days per week for four weeks at an exercise intensity of 60% maximum heart rate (HR), under either normobaric hypoxic or normobaric normoxic conditions, for 50 min (including 5 min warm-up and cool-down periods) after a 30-min rest period. Duration of follow-up: 4 weeks.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Metabolic syndrome-related markers, measured using blood sampling at baseline and 1 month
Secondary outcome measures
Body composition, measured using body composition analyzer (TANITA Co., Tokyo, Japan) at baseline and 1 month
Overall trial start date
30/03/2014
Overall trial end date
30/05/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients admitted to one of the participating wards
2. Aged 18 years or over
3. Able to provide informed consent to participate
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned sample size: 40: Japanese sample size: 40
Participant exclusion criteria
1. Coronary heart disease
2. Cardiac insufficiency
3. Pulmonary disease
4. Uncontrolled hypertension
Recruitment start date
30/03/2014
Recruitment end date
30/08/2014
Locations
Countries of recruitment
Japan
Trial participating centre
Gifu University
501-1194
Sponsor information
Organisation
University of Ulsan
Sponsor details
93 Daehak-ro
Nam-gu
Ulsan
44610
Korea
South
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Ulsan
Alternative name(s)
UOU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Korea, South
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sohee Shin.
Intention to publish date
01/11/2017
Participant level data
Available on request
Results - basic reporting
Publication summary